WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BONE STAPLE: SPEEDTITAN; STAPLE, FIXATION, BONE
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Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on an unknown date in 2021, the patient underwent surgery with the unknown bone staple and unknown screw in question.On november 12, 2021, the patient underwent revision surgery for removal of the implants in question due to breakage.The procedure outcome was reported as good.There is no further information available.This report is for one (1) unk - bone staple: speedtitan.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on an unknown date in 2021, the patient underwent surgery with the unknown bone staple and unknown screw in question.On (b)(6) 2021, the patient underwent revision surgery for removal of the implants in question due to breakage.The procedure outcome was reported as good.There is no further information available.This report is for one (1) unk - bone staple: speedtitan.This is report 1 of 2 for (b)(4).
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